Risk Management Masterclass [2023] | Certification Course

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Anil Sharma Kandel

4:31:23

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1. Introduction and Objective

1. Introduction.mp4

04:56

2. Course Objectives.mp4

06:24

2. Fundamentals for Risk Management and Quality Management System

1. What is Medical device, Pharmaceuticals and cosmetics.mp4

12:36

2. Laws and Standards for Medical device and Pharmaceuticals.mp4

05:47

3. Quality Management System (QMS) overview.mp4

08:07

4. What is Risk.mp4

11:28

5. Risk Management- Overview.mp4

10:03

3. Classes of Medical Device

1. Classes of Medical Devices.mp4

09:19

4. Quality Management Systems (QMS) standards from around the world

1. Overview of QMS system and regulatory bodies.mp4

12:26

2.1 Health Canada website for Medical Device Regulations.html

2.2 Health Canada SOR-98-282.pdf

2. QMS of Health Canada SOR98-282.mp4

08:53

3.1 CFR - Code of Federal Regulations Title 21.pdf

3.2 FDA website for 21 CFR 820.html

3. USA QMS for medical devices (21-CFR-820).mp4

12:14

4.1 Brazil- ANVISA RDC 402015 website.html

4. QMS standard of Brazil ANVISA- RDC 402015.mp4

05:59

5. Europe QMS EU 2017745 (MDR).mp4

13:59

6. Japan QMS PMDA- MHLW MO 169.mp4

08:55

7.1 ARGB-Appendix-11-Risk-Management (Austrialia).pdf

7. Australia QMS Therapeutic Goods Administration (TGA).mp4

08:01

8. International Organization of Standardization (ISO) QMS ISO 13485.mp4

12:41

5. Risk Management (RM) System per ISO 14971 standards

1.1 ISO 14971 website.html

1. Intro to Risk Management Standard (ISO14971).mp4

12:47

2. Mandated RM documents per ISO 14971.mp4

06:43

3. Risk Management Activities.mp4

13:20

6. Complete And Compliant Risk Management File

1. Types of documents used for RM activities.mp4

11:30

2. Number of RM documents for one medical device.mp4

03:05

3. Important terminologies in Risk Management.mp4

10:45

4. Risk Classification Table (Severity of harm Probability of occurrence of harm).mp4

06:47

5.1 PFMEA and DFMEA.xlsx

5. PFMEA- Understand and Create on from Scratch!.mp4

16:31

6. DFMEA and UFMEA- Create from Scratch!.mp4

10:19

7. Benefit And Drawbacks of FMEA, FTA and PHA.mp4

06:14

8. Risk Controls.mp4

05:57

9. Benefit Risk Analysis.mp4

05:33

10. Production and Post Production Activities.mp4

03:48

11. Risk Management Report.mp4

06:16

Description

Be an expert in ISO 14971 (RM) and ISO 13485 (QMS). Create risk assessment docs like DFMEA, HAZOP, HACCP from scratch

What You'll Learn?

Become an expert in creating Risk Management documents from scratch, such as PFMEA, DFMEA, HAZOP, HACCP for any enterprise.
Learn-depth on how to perform Risk Assessment, Risk Evaluation, Risk Measurement, Risk Control and Benefit-Risk Analysis!
In-depth understanding of Regulatory standards for GMP environment such as ISO 14791:2019, EU 2017/745 MDR, 21 CFR 820, SOR/98-282, ISO13485 and ISO 22000
Be proficient in what Food and Drug Administration (FDA) auditors are looking for while doing Quality audits in medical device and food industry,
Learn why CAPA, Non conformances, IQ/OQ/PQ, complaint handling process are crucial for medical device industry
Learn in-depth about Quality Management system (QMS) regulations from different countries around the world
How Risk management Activities is essential in creating a good manufacturing practice (GMP) environment.

Who is this for?

Professionals looking to be promoted or looking to get into medical device, pharmaceutical industry and food industry

What You Need to Know?

No prerequisite required. Course progresses from basic to advanced level with easy to grasp content and real world examples.

More details

Description
The most extensive course on Risk Management available in Udemy!
This course is designed to teach you everything that you need to know to become a Subject Matter Expert (SME) in Risk ManagementÂ and Quality Management System (QMS)Â within Medical device, pharmaceutical industry and any other enterprise that conducts risk management activity.
Regardless of your current skills and experience, after taking this course, you will be comfortable communicating to experts in medical device industry about Quality management systems (QMS) and risk management (RM)Â standards and regulations.
By the end of this course you will be a pro at creating complex Risk Assessment and Risk MeasurementÂ documents such as PFMEA, DFMEA, HACCP, HAZOP, Benefit-Risk Analysis, Post Market Surveillance Report (PMSR), Clinical Effects Analysis Report (CEA) from the scratch! Knowing this skills will set you apart from the crowd and you can easily land you six-figure jobs in a reputed medical device companies.
You will be well versed in rules, regulations and standards for medical device industries across the world such as ISO14971 (Risk Management, ISO) , ISO13485, ISO 22000,Â 21CFR810 (FDA, USA), RDC 40/2015 (Anvisa,Â Brazil), EU 2017/745 MDR, MHLW MO 169 (PMDA, Japan) and TGR 2002 (TGA, Austrialia) and be able to talk about them in meetings, interviews and even with auditors.
You will learn how processes like complaint reviews, Corrective and Preventative Maintenance (CAPA), Process Validation (PV), Equipment Qualification (IQ/OQ/PQ) ties into Risk Management and why companies need to do these activities.
Whether you are just getting into Risk Management, or wants to freshen up your skills, or are looking to advance your career in the field, this course can provide you with more than enough knowledge to be the top 5% in your organization.

Note: This course is directly related to and applies to Enterprise Risk Management (ERM). Medical device and Pharmaceutical companies are an enterprises themselves so this course teaches you everything you need to know to manage risks in an enterprise.Â In fact, you will learn risk management in so much in-depth from this course that you can tackle risk management activities on any enterprise.
Note: This course also ties into Financial Risk Management (FRM)Â as we go in depth on the types of risks companies deals with, and financial risk is one of them. Hence students wanting to learn FRMÂ can also greatly benefit from this course.
Who this course is for:
Professionals looking to be promoted or looking to get into medical device, pharmaceutical industry and food industry

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Anil Kandel lives and works in United States of America.Hi! Anil Sharma Kandel is an Industrial Engineer by education with vast experience in the Medical Device Industry. He has worked on Risk Management Activities for numerous commercial products and authored pilot risk management files for products in clinical trial phase and for commercial products. Throughout his career he has received several high level trainings in Risk Management Activities and CAPA activities and adding it to his years of experience in Risk management. He feels confident that he would be able to provide his students with the expert level knowledge and skills to be the top 5% in any enterprise.

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